The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Bio-interference Screw, 7 Mm, 8 Mm, 9 Mm.
Device ID | K971358 |
510k Number | K971358 |
Device Name: | BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | ARTHREX, INC. 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan ARTHREX, INC. 555 THIRTEENTH ST., N.W. Washington, DC 20004 -1109 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-04-11 |
Decision Date | 1997-07-09 |
Summary: | summary |